scholarly journals A drug-coated balloon treatment for urethral stricture disease: Two-year results from the ROBUST I study

2020 ◽  
Vol 15 (2) ◽  
Author(s):  
Rachel A. Mann ◽  
Ramon Virasoro ◽  
Jessica M. DeLong ◽  
Rafael E. Estrella ◽  
Merycarla Pichardo ◽  
...  

Introduction: Mechanical balloon dilation and direct visualization internal urethrotomy (DVIU) are the most widely used treatments for urethral stricture disease in the U.S., but recurrence rates are high, especially after re-treatment. This study investigates the safety and efficacy of the Optilume™ paclitaxel-coated balloon for the treatment of recurrent strictures. Methods: Men with recurrent bulbar strictures ≤2 cm with 1–4 prior endoscopic treatments were treated with the Optilume™ drug-coated balloon. Patients were evaluated within 14 days, three, six, 12, and 24 months post-treatment. The primary safety endpoint was serious urinary adverse events. The primary efficacy endpoint was ≥50% improvement in International Prostate Symptom Score (IPSS) at 24 months. Secondary outcomes included quality of life, erectile function, flow rate, and post-void residual urine volume. Results: A total of 53 subjects were enrolled and treated; 46 completed the 24-month followup. Forty-three percent of men had undergone >1 previous dilations, with a mean of 1.7 prior dilations. There were no serious adverse events related to treatment at two years. Success was achieved in 32/46 (70%), and baseline IPSS improved from a mean of 25.2 to 6.9 at 24 months (p<0.0001). Quality of life, flow rate, and post-void residual urine volumes improved significantly from baseline. There was no impact on erectile function. Conclusions: Two-year data indicates the Optilume™ paclitaxel-coated balloon is safe for the treatment of recurrent bulbar urethral strictures. Early efficacy results are encouraging and support further followup of these men through five years, as well as further investigation with a randomized trial.

2014 ◽  
Vol 21 (2) ◽  
Author(s):  
Ervita Mediana ◽  
Irfan Wahyudi ◽  
Arry Rodjani

Objective: To evaluate the overall outcomes of patients who get definitive treatment of urethral stricture. Material & Method: All patients who underwent various urethral stricture management in Cipto Mangunkusumo Hospital were evaluated over 1 year period. Patient demographics, type of surgery, International Prostate Symptoms Score (IPSS), quality of life (QoL) score, flow rate (FR) and post void residual urine (PVR) of all patients were evaluated at 3 months, 6 months and 1 year after surgery. Results: Out of 230 urethral stricture patients, 65 patients were eligible this study. Mean patient age was 41.19 ± 20.44 years. 37Direct Vision Internal Urethrotomy (DVIU), 20 end-to-end anastomosis, and 8 graft urethroplasties were performed. All patients underwent urethral stricture management showed improvement of IPSS (-22.64, p < 0.001), QoL (-3.36, p < 0.001), FR (16.72 ml/s, p < 0.001) and PVR (-126.23 ml, p < 0.001). Compliant patients showed better improvement of IPSS and FR than non compliant patient after DVIU procedure. Overall, open surgery give better improvement of IPSS and FR than DVIU procedure. These differences were more pronounced in recurrent and long (≥ 2 cm) urethral stricture disease. In open surgery group, end-to-end anastomosis give better improvement in FR compared to graft urethroplasty. Conclusion: Patients undergoing urethral stricture management experienced a significant improvement in self-reported outcomes and functional uroflow studies. Overall, open surgery gives better improvement in FR and IPSS than DVIU procedure. In open surgery group, end-to-end anastomosis give better improvement compares to graft urethroplasty.Keywords: International Prostate Symptoms Score, quality of life, flow rate, post void residual urine, urethral stricture.


2019 ◽  
Vol 2019 ◽  
pp. 1-9 ◽  
Author(s):  
Pieter D’hulst ◽  
Michael S. Floyd ◽  
Fabio Castiglione ◽  
Kathy Vander Eeckt ◽  
Steven Joniau ◽  
...  

Background. Excision and primary anastomotic (EPA) urethroplasty remains the gold standard definitive treatment for short urethral stricture disease. For patients, postoperative erectile function and quality of life are the main goals of the surgery. Patient-reported outcome measures (PROMs) are therefore of major importance. Objective. The objective of this study was to prospectively analyse functional outcomes and patient satisfaction. Design, Settings, and Participants. We prospectively evaluated 47 patients before and after EPA from August 2009 until February 2017. The first follow-up visit occurred after a median of 2.2 months (n = 47/47), with the second and third follow-ups occurring at a median of 8.5 months (n = 38/47) and 20.2 months (n = 31/47). Before surgery and at each follow-up visit, the patients received five questionnaires: the International Prostate Symptom Score (IPSS), the International Prostate Symptom Score with the Quality of Life (IPSS-QOL) score, the Urogenital Distress Inventory Short Form (UDI-6) score, the International Index of Erectile Function-5 (IIEF-5) score, and the ICIQ-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS-QOL) score. Surgical Procedure. Surgery was performed in all cases using the same standardized EPA technique. Outcome Measurements and Statistical Analysis. Voiding symptoms, erectile dysfunction, and quality of life were analysed using paired sample t-tests, with a multiple-testing Bonferroni correction. Any requirement for instrumentation after surgery was considered treatment failure. Results and Limitations. Patients with mild or no baseline erectile dysfunction showed significant decline in erectile function at first follow-up (mean IIEF-5 of 23.27 [standard deviation; SD: 2.60] vs. 13.91 [SD: 7.50]; p=0.002), but this had recovered completely at the third follow-up (IIEF-5: 23.25 [SD: 1.91]; p=0.659). Clinically significant improvements were noted in IPSS, IPSS-QOL-score, UDI-6-score, and ICIQ-LUTS-QOL-score at the first follow-up (p<0.0001). These improvements remained significant at the second and third follow-ups (p<0.0001) for all PROMs. Three of the patients experienced stricture recurrence. The main limitations of this study were incomplete questionnaires, loss to follow-up, and low number of patients. Conclusions. EPA results in an initial decline in erectile function, but full recovery occurred at a median of 20 months. Voiding improved significantly, and a major improvement in quality of life was noted, which persisted for up to 20 months after surgery. Patient Summary. This study showed the importance of patient-reported outcome measures in indicating the actual outcome of urethral stricture disease surgery.


2019 ◽  
Vol 48 (4) ◽  
pp. 030006051988554
Author(s):  
Xia Shen ◽  
Chun-lan Wang ◽  
Wan-ying Wu ◽  
Guan-mian Liang ◽  
Li-yao Xia

Objective To identify the benefits of clean intermittent self-catheterization in women who have late bladder dysfunction caused by radical hysterectomy in cervical cancer. Methods Thirty women who underwent radical hysterectomy with late bladder dysfunction were recruited. A nursing intervention program focusing on clean intermittent self-catheterization and a drinking plan was implemented. We recorded urinary times during the day and night, post-voiding residual urine volume, positive catheter specimen of urine rate, and quality of life instruments for patients with cervical cancer . Results All patients were able to satisfactorily manage clean intermittent self-catheterization following video-based operational training. Bladder function was significantly increased after 3-month intervention compared with before the intervention. Urinary times during the day and night, and post-voiding residual urine volume were greatly decreased post-intervention compared with pre-intervention. The rate of a positive catheter specimen of urine test significantly decreased over time. There was significant improvement in quality of life in five dimensions between weeks 1 and 12 following the intervention. Conclusions Patients are able to learn the technique of clean intermittent self-catheterization without any difficulty. This technique is effective together with a drinking plan to decrease late bladder dysfunction caused by radical hysterectomy in cervical cancer.


2016 ◽  
Vol 2016 ◽  
pp. 1-4 ◽  
Author(s):  
Jonathan R. Weese ◽  
Valary T. Raup ◽  
Jairam R. Eswara ◽  
Stephen D. Marshall ◽  
Andrew J. Chang ◽  
...  

Purpose. To quantify the quality of life (QoL) distress experienced by immediate family members of patients with urethral stricture via a questionnaire given prior to definitive urethroplasty. The emotional, social, and physical effects of urethral stricture disease on the QoL of family members have not been previously described.Materials and Methods. A questionnaire was administered prospectively to an immediate family member of 51 patients undergoing anterior urethroplasty by a single surgeon (SBB). The survey was comprised of twelve questions that addressed the emotional, social, and physical consequences experienced as a result of their loved one.Results. Of the 51 surveyed family members, most were female (92.2%), lived in the same household (86.3%), and slept in the same room as the patient (70.6%). Respondents experienced sleep disturbances (56.9%) and diminished social lives (43.1%). 82.4% felt stressed by the patient’s surgical treatment, and 83.9% (26/31) felt that their intimacy was negatively impacted.Conclusions. Urethral stricture disease has a significant impact on the family members of those affected. These effects may last decades and include sleep disturbance, decreased social interactions, emotional stress, and impaired sexual intimacy. Treatment of urethral stricture disease should attempt to mitigate the impact of the disease on family members as well as the patient.


2020 ◽  
Vol 17 (1) ◽  
pp. 3-8
Author(s):  
Md Waliul Islam ◽  
Parveen Sultana ◽  
Abdul Matin Anamur Rashid Choudhury ◽  
Tasmina Parveen ◽  
Md Nurul Hooda

Objective: To determine the improvement of the quality of life in patient of BPH after transurethral resection of prostate. Methods: A total of 102 of patients complaining lower urinary tract symtoms due to Benign prostatic hyperplasia (BPH). Each of the patient was followed up at 8 weeks (1st visit), 16 weeks (2nd visit) and 24 weeks (3rd visit) after transurethral resection of prostate (TURP). Before TURP for base line study of each patient was evaluated by history, physical examination, digital rectal examination (DRE), International Prostate Symptoms Score (IPSS), Quality of Life Score (QOL), Urinalysis, volume of the prostate and post voidal residual urine (PVR) were determined by ultrasonogram. Improvement of lower urinary tract symptoms and quality of life was determined using IPSS. Improvement was based on the changes from base line in symptoms,urinary flow rate, amount of post voidal residual urine and quality of life.Urine flow rate was measured by uroflowmetry as peak urinary flow rate (Qmax), voiding time and voided volume and was considered valid only if the voided volume was >200 ml. Symptoms were assessed using IPSS & consisting of seven symptoms (frequency, nocturia, urge in continence, urgency, hesitancy, terminal dribbling and sense of incomplete evacuation) that were graded from 0-5. An overall symptoms score was calculated. Result: 102 cases were evaluated by history, physical examination, digital rectal examination (DRE), international prostate symptom scoring (IPSS), quality of life (QOL) scoring, uroflowmetry, post voided residual urine (PVR) and volume of prostate by USG and serum prostate specific antigen (PSA). Cases were selected between 60-75 years. In group-A, among 42 cases (41.2%) <65 years and group-B, 60 cases (58.80%) > 65 years. Age of the patients of each group was compared with IPSS, PVR, Qmax and QOL. Before TURP, IPSS range 17-25 and mean 21.61+2.43, after TURP, range 0-7 and mean 4.27+1.71). There was significant correlation between the IPSS obstructive scores and Qmax at base line (P=<0.001), while correlations at the 1st, 2nd and 3rd follow up significant. There was also a significant correlation between IPSS obstructive score and PVR, and quality of life. After TURP, the IPSS Score showed significant improvements in urinary symptoms with the IPSS showing more significant change for obstructive symptoms. A significant improvement of IPSS was found from 2 months to 6 months follow up after TURP. The change was tested using “paired student ‘t’ test”. Mean quality of life was 5.01+0.64 at base line, which became 0.60+0.91 at end point and therefore change of mean QOL was -4.41+0.93 ml. A significant improvement QOL after transurethral resection of the prostate. The change was test using ‘Paired Student‘t’ test’. The change was found significant (P=<0.001). Conclusion: Transurethral resection of prostate resolves obstructive symptoms, rapid improvement of urinary flow rate and quality of life that is why it is considered as gold standard treatment for moderate to severe symptomatic BPH patients. Bangladesh Journal of Urology, Vol. 16, No. 1, Jan 2014 p.3-8


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